BEUDAMED
    FDA Recall Terminated

    Dimension LIP Flex Reagent Cartridge, Catalog# DF55A

    Recall: Z-0588-2011 · Initiated March 10, 2010

    Recall

    Recall Number
    Z-0588-2011
    Event Number
    55571
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    CHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 10, 2010
    Posted
    December 10, 2010
    Terminated
    August 4, 2011
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dimension LIP Flex Reagent Cartridge, Catalog# DF55A

    Reason

    Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration.

    Action

    Recalling firm issued "Urgent Field Safety Notice", dated March 2010, informing users of the problem and to transition to the revised Lipasae method.

    Distribution

    Nationwide Distribution throughout the US.

    Quantity

    21171